Clinical-stage biopharmaceutical company Adocia (Euronext Paris:ADOC), based in France, and Chinese pharmaceutical company Tonghua Dongbao Pharmaceutical Co Ltd (SHSE:600867) on Wednesday announced positive topline results from a Phase 3 clinical trial in China evaluating BioChaperone Lispro (THDB0206 injection), an ultra-rapid insulin for adults with Type 1 diabetes.
The study, approved by China's Center for Drug Evaluation, met its primary endpoint by demonstrating non-inferior HbA1c reduction at 26 weeks compared with Humalog, the standard of care from Eli Lilly (NYSE:LLY).
The trial also achieved a key secondary endpoint, showing a statistically significant reduction in post-meal blood glucose rise for patients receiving THDB0206. Continuous monitoring confirmed improved glucose control one hour after each meal across breakfast, lunch, and dinner.
Conducted on 550 Chinese adults with inadequate glycaemic control, the study found that THDB0206 demonstrated good safety and tolerability, with adverse and hypoglycaemic event rates comparable to Humalog.
These findings confirm and extend positive results previously observed in Type 2 diabetes patients. BioChaperone Lispro, licensed to Tonghua Dongbao in 2018 for China and parts of Asia, combines Adocia's proprietary BioChaperone technology with insulin lispro to enable faster glucose control and greater dosing flexibility.
Under the licensing agreement, Adocia is eligible for a USD20m milestone payment upon Chinese marketing authorisation and double-digit royalties on future sales.
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